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Clinical Trials/ISRCTN09187060
ISRCTN09187060
Completed
Not Applicable

A pilot randomised controlled study of oxygen delivery via Vapotherm® in infants with severe acute bronchiolitis

Record Provided by the NHSTCT Register - 2007 Update - Department of Health0 sites32 target enrollmentSeptember 28, 2007
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Enrollment
32
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 28, 2007
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional

Investigators

Sponsor
Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Eligibility Criteria

Inclusion Criteria

  • •Subjects will be infants less than 12 months of age admitted to hospital with a clinical diagnosis of
  • •1\. Bronchiolitis (clinical picture of cough, tachypnoea, chest retraction and crackles on auscultation) and
  • •2\. Features of severe disease:
  • •2\.1 Head\-box oxygen requirement greater than 50% to maintain SpO2 at least 92%
  • •2\.2 Feeds have been discontinued, and intravenous fluid started
  • •2\.3 Moderate to severe tachypnoea and increased work of breathing
  • •2\.4 Triggering of the Paediatric Early Warning Tool

Exclusion Criteria

  • •1\. Congenital cyanotic heart disease
  • •2\. Repeated severe apnoeas
  • •3\. Requirement for resuscitation with bag\-mask ventilation
  • •4\. Severe hypercapnia (increased carbon dioxide) with acidosis on blood gas analysis of pH less than 7\.2
  • •5\. Parental refusal or inability to give consent

Outcomes

Primary Outcomes

Not specified

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